EXTRA STRENGTH GAS RELIEF- simethicone capsule, liquid filled

EXTRA STRENGTH GAS RELIEF by

Drug Labeling and Warnings

EXTRA STRENGTH GAS RELIEF by is a Otc medication manufactured, distributed, or labeled by Geri-Care Pharmaceuticals, Corp. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each softgel)

Simethicone 125 mg

Purpose

Anti-Gas

Use

for the relief of pressure, bloating, and fullness commonly referred to as gas

Warnings

If pregnant or breast feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

• adults: swallow with water 1 or 2 softgels as needed after meals and at bedtime
• do not exceed 4 softgels in 24 hours except under the advice and supervision of a physician

Other information

• Tamper Evident: Do not use if imprinted seal under cap is missing or broken.
• store at controlled room temperature

Inactive ingredients

D&C yellow #10, FD&C blue #1, FD&C red #40, gelatin, glycerin, peppermint oil, sorbitol special, titanium dioxide, water

package label

INGREDIENTS AND APPEARANCE

EXTRA STRENGTH GAS RELIEF 
simethicone capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57896-792
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	125 mg

Inactive Ingredients
Ingredient Name	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
GELATIN (UNII: 2G86QN327L)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GLYCERIN (UNII: PDC6A3C0OX)
PEPPERMINT OIL (UNII: AV092KU4JH)
MANNITOL (UNII: 3OWL53L36A)

Product Characteristics
Color	green	Score	no score
Shape	OVAL	Size	9mm
Flavor		Imprint Code	IS05
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57896-792-05	50 in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part332	01/01/2017

Labeler - Geri-Care Pharmaceuticals, Corp (611196254)

Registrant - Geri-Care Pharmaceuticals, Corp (611196254)